BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2192178 · Received August 4, 2011

    Report

    Report Number
    3006630150-2011-01202
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 12, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: DEVICE: SC-2366-50, (B)(4), DESCRIPTION: LINEAR 3-6 LEAD 50CM DEVICE: SC-2366-50, (B)(4), DESCRIPTION: LINEAR 3-6 LEAD 50CM A REVIEW OF THE MANUFACTURING DOCUMENTATION OF THE EXPLANTED DEVICES FOUND THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE REPORTED EVENT OCCURRED DURING MANUFACTURING. A REVIEW OF STERILIZATION RECORDS FOUND THEM TO BE SATISFACTORY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S SCS DEVICE WAS EXPLANTED BECAUSE THE LEADS WERE EXITING THE LEAD INCISION AND HANGING OUT AND THE IPG SITE WAS RED, SWOLLEN AND ACHING. THE PATIENT WILL NOT DISCLOSE ANY ADDITIONAL INFORMATION REGARDING THE EVENT. THE PATIENT IS REPORTEDLY DOING WELL FOLLOWING THE EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention